District Court Dismisses “Failure to Warn” Claim Against Pharmaceutical Company

The United States District Court for the Middle District of Pennsylvania recently dismissed a “failure to warn” case against a drug manufacturer, holding that the manufacturer was not required to provide physicians with detailed instructions about the monitoring of signs and symptoms that were related to the drug’s potential side effects.

The underlying case, Bergstresser v. Bristol-Myers Squibb Co., No. 12-1464 (M.D. Pa. 2013), involved a patient who was prescribed Abilify by his psychiatrist for ongoing depression. After his psychiatrist increased the dosage, the patient developed a neurological disorder known as dystonia, which is characterized by symptoms of involuntary muscle contractions and abnormal posturing.

In May 2013, the patient filed suit against Abilify’s manufacturer, Bristol-Myers Squibb Co. The complaint alleged that the label for the drug was deficient, as it failed to provide instructions to physicians on how to monitor for signs and symptoms of dystonia. The plaintiff also claimed that the label failed to provide directions to physicians on how to properly increase or decrease a patient’s dose of Abilify, so that the development of dystonic symptoms could be avoided.

Counsel for Bristol-Myers Squibb filed a motion to dismiss plaintiff’s claim, which was subsequently granted by the court. In its opinion, the court found that the label for Abilify actually did “identify the contraction of dystonia as a possible reaction to taking Abilify.” However, because this condition was listed only as a potential “adverse reaction,” the court held that the label was not required to include instructions pertaining to the monitoring of dystonic side effects. Rather, with regard to patient monitoring, the court stated that only the “most clinically significant information” had be included in the label.

In support of its holding, the court also relied on the doctrine of the learned intermediary, noting that a drug manufacturer’s duty to the consumer may be discharged if the manufacturer provides a proper warning to the consumer’s physician. Recognizing that “judgments as to specific monitoring are better left to the physicians’ discretion,” the court thereby concluded that the manufacturer was not required to provide such detailed information as alleged by plaintiff. According to the court, to do so would essentially supplant the medical judgment of the physician, who the court deemed to be “in the best position to monitor and treat [his or her] patient.”